Electrochemotherapy appears to be safe and comparable to surgery in achieving control in squamous cell carcinoma of the head and neck (SCCHN), according to data presented this week at the International Conference on Head and Neck Cancer in Toronto.
OncoSec Medical, a company developing the OncoSec Medical System (OMS) ElectroOncology therapies to treat solid tumors, presented data from an interim analysis of two randomized phase III clinical trials, HNBE-01 and HNBE-02, using electrochemotherapy to treat locally recurrent and second primary SCCHN.
Initiated in 2004 and subsequently closed in 2007, the trials were conducted at 22 sites in the U.S., Canada, and Eastern and Western Europe. Of the 214 enrolled subjects, 130 were randomized into HNBE-01 and 84 into HNBE-02. This study was terminated at the interim point following an independent data monitoring committee review; however, all treated patients were followed for up to two years to evaluate safety and efficacy. At the time of this analysis, there were 98 evaluable subjects, 58 from HNBE-01 and 40 from HNBE-02.
In these studies, electrochemotherapy was compared with surgery for quality of life, safety, survival, and local control at eight months, in which local control is defined as destruction of the treated tumor without evidence of reappearance of the tumor at the treatment site.
The researchers found no statistically significant differences between time to death or local control rate at eight months between the control and experimental groups for HNBE-01 or HNBE-02, or the combination of both studies.
Quality of life was evaluated using the performance status scale for head and neck cancer patients (PSSHN), a functional outcome measurement assessing the ability to swallow, normalcy of diet, and ability to eat in public. Assessment of quality of life by the PSSHN score showed a mean score of 269 at baseline and 248 at eight months for the control group (p = 0.036) versus 257 at baseline and 249 at eight months for the electrochemotherapy group (p = 0.59).
This therapy represents a viable alternative to potentially major surgical interventions for this patient population, in which recurrent tumors in SCCHN usually have a poor prognosis with a local control rate of 40% to 50% and frequently associated loss of organ function, the researchers concluded.